The
labelling as per the draft notification would need to list all the
ingredients with official and botanical names for herbal ingredients
along with parts used and form of ingredient, in which, it is used in
the formulation, with its quantity.

The Association of
Manufacturers of Ayurveda Medicines (AMAM) has taken serious objection
to this move in a representation made on May 15, 2012. “Even if the
manufacturers implement the same it may become impractical since the
space on the label is just sufficient to comply with the current
requirement of Rule 161 of the Drugs & Cosmetics Rules”, stated
Pradeep Multani, Hon. Gen. Secretary, AMAM.

“While we appreciate
the intent of the government to make the consumers more informed, there
is a serious practical issue to include these details which the
department of Department of Ayush needs to consider,” he added.

Most
of the formulations in the Ayurveda texts are multi-ingredient. Even
the Ayurvedic Formulary of India has provided that Analysis of Ayurvedic
Formulations covered in Active Pharmaceutical Ingredient (API) Vol. I
& II covering solids, semi solids and liquids has detailed the
percentage of product containing up to 10 and above 20 ingredients,
pointed out AMAM.

The label of Dashmularishta bottle falls short
of writing the 62 ingredients and being a glass bottle, it is not
possible to provide such a big bottle in a carton. “We fail to
understand the necessity of this amendment to provide information on the
label which is already submitted to the Licensing Authority during
submission of manufacturing license application. The additional
requirement regarding ingredients being asked for through this amendment
is more of academic value to the subject expert and the consumers may
not benefit from it. On the contrary, consumer know common names more
than botanical names,” pointed out the Hon. Gen. Secretary, AMAM.

Classical
ayurvedic products have limited f manufacturers. The industry is
apprehensive on the amendment which is currently circulated as draft
notification to seek comments.

In order to further, convince the
Department of Ayush, the Association in its representation has insisted
to give up or cancel the notification. It also went on to enclose a
sample of the label for Mahasudarshan Churna as per the existing Rule
161 and modified one.

MahaSudarshan Churna manufactured by Dabur
India Limited provided the Book Reference as ‘Ayurveda Sar Samgraha’.
Besides providing details of the indications for which the churna, there
was information on dosage, net weight, MRP, batch number, storage and
shelf life along with a long list of over 100 herbs.

The
Association views that the move to add extra information on the label
would become counterproductive and may not serve the purpose.

“It
is possible that this move is aimed to satisfy consumers needs and
right to information. Providing additional on the label would add to
cost and cause logistical problems. Creative solutions are needed to
handle the issue. A viable move would be to make it mandatory for
manufacturers to provide all details on their websites and mention this
on the label,” said Dr DBA Narayana, an eminent pharmacist and
regulatory expert.